Pharmacokinetic, Safety, and Tolerability Study of Risperidone ISM® at Different Dose Strengths

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial is designed to evaluate different dosages of risperidone ISM, a new long-acting injectable form.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rovi Pharmaceuticals Laboratories
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• Capable of providing informed consent.

• Male or female aged ≥ 18 years to < 65 years

• Current diagnosis of schizophrenia or schizoaffective disorder, according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders Clinical Trials (SCID-CT) or the DSM-IV-TR

• Medically stable over the last month, and psychiatrically stable without significant symptom exacerbation over the last three months based on the investigator's judgment

• Score of ≤ 4 (moderately ill) on the Clinical Global Impression - Severity of Illness (CGI-S)

• If a sexually active female of childbearing potential, using a medically accepted contraceptive method.

Exclusion Criteria:

• Presence of an uncontrolled, unstable, clinically significant medical condition that in the opinion of the investigator may interfere with the interpretation of safety and PK evaluations

• If female, a positive serum pregnancy test, or planning to become pregnant between now and one month after the last dose of trial medication, or currently breastfeeding a child

• History of neuroleptic malignant syndrome and current or past history of tardive dyskinesia

• Positive urine drug/alcohol screen finding, unless the positive finding can be accounted for by documented prescription use.

• In the investigator's opinion, at imminent risk of committing self-harm

• Use of depot antipsychotics within the last three months

• Receipt of any investigational drugs within the last three months

• Current participation in any other clinical trial